Hawaii Marijuana Testing License

Does Hawaii Require Testing for Marijuana and Marijuana Products?

The Hawaii Administrative Rules $11-850-81 requires dispensary licensees to ensure their marijuana and marijuana products are tested by a laboratory certified by the Hawaii State Department of Health before dispensing. In addition, Hawaii Revised Statutes 329D-8 provides that the Hawaii State Department of Health initiates and implements standards for laboratory testing of marijuana and marijuana products. In accordance with this requirement, the department licenses marijuana testing laboratories to test cannabis and cannabis products for content, consistency, and contamination. In establishing these standards, the Hawaii State Department of Health shall:

Examine and accept recommendations from the testing standards and programs employed in other jurisdictions
Examine and accept recommendations from the testing standards and programs for pesticides under the ordinances of the United States Environmental Protection Agency
Review the impact of the standards on the product’s retail cost to the qualifying patient;
Review processes that may permit cannabis or cannabis products that fail testing standards to be remediated
Incorporate permission for qualifying patients and primary caregivers to receive testing services directly from certified laboratories on the island in which the qualifying patient and primary caregiver is domiciled
For the testing for microbiological impurities, consider the benefits of organically grown cannabis that features the use of bacteria in place of pesticides

The Hawaii Administrative Rules 11-850 requires certified testing laboratories to conduct specific tests to ensure the safety of cannabis products sold to registered patients in the state. These tests include:

The chemical profile of the batch for the compounds is listed below:
- Delta 9 Tetrahydrocannabinol (THC)
- Tetrahydrocannabinol Acid (THCA)
- Cannabinol (CBN)
- Cannabidiol (CBD)
- Cannabigerol (CBG)
- Cannabidiolic Acid (CBDA)
The presence of the contaminants, which shall not be more than the following levels:
- Heavy metals:
  - Mercury 2 ppm
  - Cadmium 4 ppm
  - Lead 6 ppm
  - Arsenic 10 ppm
- Pesticides regulated by the United States Environmental Protection Agency: 1 ppm
- Solvents:
  - Toluene 1 ppm
  - Benzene 1 ppm
  - Hexane 10 ppm
  - Butane 800 ppm
  - Heptanes 500 ppm
  - Total Xylenes (m, o, p-xylene) 1 ppm
- Any visible alien or extraneous material not intended to be part of the cannabis product being manufactured, such as mold, insects, metal, plastic, or hair
- Moisture content of plant material
- Microbiological impurities, such as:
  - Total Viable Aerobic Bacteria:
    - Unprocessed and Processed Materials: 10⁵ Colony Forming Unit (CFU)/g
    - CO₂ and Solvent-Based Extracts: 10⁴ CFU/g
  - Total Yeast and Mold:
    - Unprocessed and Processed Materials: 10⁴ CFU/g
    - CO₂ and Solvent-Based Extracts: 10³ CFU/g
  - Total Coliforms:
    - Unprocessed and Processed Materials: 10³ CFU/g
    - CO₂ and Solvent-Based Extracts: 10² CFU/g
  - Bile-tolerant Gram-Negative Bacteria:
    - Unprocessed and Processed Materials: 10³ CFU/g
    - CO₂ and Solvent-Based Extracts: 10² CFU/g
  - Escherichia coli (pathogenic strains) and Salmonella spp.: Not detected in 1g
  - Aspergillus fumigatus, Aspergillus flavus, Aspergillus niger: <1 CFU/g
  - Mycotoxins: <20 μg (micrograms): of any mycotoxin per kg of material
  - Any other tests required by the Hawaii State Department of Health shall also be conducted

Does Hawaii License Independent Marijuana Testing Facilities?

Yes, Hawaii licenses independent testing facilities that qualify after the Hawaii State Department of Health has reviewed their applications. The state does not have a state agency that is responsible for testing marijuana and marijuana products. However, the Hawaii State Department of Health licenses and regulates certified testing facilities in the state. As of early 2024, there is only one certified testing facility in Hawaii, down from the initial four licensed facilities.

What Accreditations Do Marijuana Testing Facilities Need in Hawaii?

Testing laboratories in Hawaii are required to meet the specific laboratory accreditation standards of the International Organization for Standardization (ISO). This entails possessing a certificate of ISO/IEC 17025:2017 accreditation and related audit reports by an approved accreditation or credentialing body. The ISO/IEC 17025:2017 accreditation is the international reference for testing laboratories. Entities looking to obtain certification from the State Department of Health to operate testing laboratories must be ISO/IEC 17025:2017 accredited. Otherwise, they may be accredited in Hawaii by an accreditation body whose standards are equivalent to the International Standards for Organization ISO 17025. They must also have established standard operating procedures that include a chain of custody for samples transferred to the laboratory for testing.

However, the department may grant a provisional certification to a laboratory to test marijuana and marijuana products provided the laboratory:

Has applied to be ISO 17025 accredited in International Standards for Organization (ISO);
Is owned or managed by a laboratory accredited in another jurisdiction by an accreditation body whose standards are similar to the ISO 17025; or
Has fulfilled all other criteria for the laboratory certification

The requirements for ISO-IEC 17025:2017 accreditation include:

1. General requirements

This section entails that the laboratory fulfills the impartiality and confidentiality standards for the ISO 17025. The general requirements provide that laboratory activities must be adequately organized, structured, and handled to ensure impartiality to avoid biased results from being created. A testing laboratory is charged with ensuring the impartiality of its laboratory activities. I also prevent commercial, financial, or relationship pressures that may jeopardize its impartiality and confidentiality. The laboratory is required to notify its customers before it puts out their customer’s personal information in the public domain, ensuring that the customer’s personal information is protected.

2. Structural requirements

The structural requirements provide that the laboratory must be a legal entity. These requirements address the laboratory’s organizational structure and define the responsibility, authority, and interrelationship of all personnel who engage in different aspects of the laboratory’s activities. The different activities, including laboratory activities performed at its permanent facilities, mobile facilities, associated temporary facilities, or customer's facilities, must be performed in accordance with the ISO/IEC 17025:2017 requirements.

3. Resource requirements

Under resource requirements, a laboratory must have systems and support services, personnel, facilities, equipment that administers and performs its laboratory activities. The competence requirements, roles, responsibilities, and personnel authorities shall be formulated and communicated to the personnel. The laboratory shall regulate the use of externally provided products and services that influence laboratory activities.

4. Process requirements

Process requirements include the instructions, procedures, guidelines, manuals, standards, and reference data that are of relevance to laboratory activities, comprising:

Sampling
Complaints
Handling of Test and Calibration Items
Selection, verification, and validation of methods
Review of Requests, Tenders, and Contracts
Selection, Verification, and Validation of Methods
Evaluation of Measurement Uncertainty
Technical Records
Ensuring the Validity of Results
Nonconforming Work
Control of Data and Information Management

5. Management system requirements

The management system requirements provide that the laboratory shall establish, implement, record, and maintain a management system capable of supporting the constant fulfillment of the ISO/IEC 17025:2017 requirements and ensuring the quality of the laboratory results. The laboratory shall implement a management system consistent with Option A or Option B as defined in the requirements.

How to Get a Marijuana Testing Laboratory License in Hawaii

Applicants can get a marijuana testing laboratory license from the Hawaii State Department of Health provided they qualify for certification. A medical marijuana testing facility applicant shall provide the following during application:

All information and documentation required by the department. The required information and documentation are specified in the Medical Cannabis Testing Facility Application form. Some of the required information are:
- Legal name of laboratory or facility
- Facility address
- Mailing address, if different from physical location
- Name and contact information of director or manager, contact person, and quality assurance officer
The electronic version of the required documentation to be submitted with the application and certification fee are:
- Management systems documentation
- A written security policy that describes the techniques and devices that will be used to secure cannabis products in the laboratory
- A description of facilities and equipment that will be used in the operation of the testing facility and equipment information
- Employees documentation
  - A list of employees of the testing facility, including their education, qualification, and experience
  - Training document for each employee of the testing facility
  - Documentation that analysts are competent in the analytical and administrative procedures (Initial, six months, and the year after)
- Procedures documentation, including:
  - A list of the procedures and products used for each medical cannabis analyte
  - Documentation showing that the analytical procedures the laboratory uses are suitable for their intended purposes
  - Standard Operating Procedures used by the facility
  - Sample management
- Quality systems manual
A copy of the testing facility’s most recent assessment by the testing facility’s accreditation body and the testing facility’s responses to any discoveries of non-compliance with standards or recommendations; and
A copy of the laboratory's accreditation in Hawaii or another jurisdiction, accompanied by the scope of accreditation

The completed form must be signed, dated, and packaged with the necessary documentation. The application packet and fee should be submitted by certified mail to:

State Laboratories Division

2725 Waimano Home Road

Pearl City, HI 96782

After the completed application form has been submitted alongside the required documentation and fee, the testing facility will undergo an on-site inspection and evaluation. The applicant will also be required to demonstrate capacity and proficiency to test cannabis and cannabis products before the State Department of Health Can approve them. The department shall not approve the application for certification if the laboratory does not meet the set requirements.

When the Hawaii State Department of Health certifies a laboratory, the laboratory is required to:

Display a copy of the certification in a visible location on the laboratory premises.
Follow the scope for which it is accredited for testing cannabis and cannabis products and the requirements for laboratory standards and testing.
Initiate standard operating procedures to test cannabis and cannabis products.
Inform the department within one business day after it receives a notification of any kind that its accreditation has been denied, suspended, or revoked.
Fulfill every requirement outlined in the certification as issued by the department.

How Much Does a Marijuana Testing Laboratory License Cost in Hawaii?

The certification fee for a marijuana testing laboratory is $3,000, and it is to be paid to the Hawaii State Department of Health via certified check, cashier’s check, or money order. It should be noted that personal and company checks will not be accepted. A marijuana testing laboratory certification shall expire one year after the date it was issued, but it may be renewed if the laboratory:

Requests renewal in writing within three months before the expiration
Provides documentation indicating that it still complies with the requirements for certification of laboratories
Pays the $3,000 renewal fee to the Hawaii State Department of Health

A marijuana testing facility’s certification may be extended beyond the one-year expiration at the department’s discretion if the laboratory timely requests renewal of its certification and approves the extension in writing prior to the expiration date.

Are there Local Regulations for Cannabis Testing Facilities in Hawaii?

There are no local regulations for cannabis testing laboratories in Hawaii. Cities and counties do not locally regulate cannabis testing facilities for chemical exposure, air quality, odor control, ventilation requirements, standards, etc. Cannabis testing facilities in Hawaii are centrally certified and regulated by the Hawaii State Department of Health.